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AbbVie files to market all-oral, interferon-free HCV treatment in Europe
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AbbVie announced that it submitted marketing authorization applications to the European Medicines Agency for its investigational combination treatment for adult patients with chronic hepatitis C virus genotype 1 infection, according to a company press release.
The all-oral, interferon-free regimen consists of a fixed-dose combination of the protease inhibitor ritonavir (ABT-450), at 100 mg/150 mg, co-formulated with 25 mg ombitasvir (ABT-267), administered once daily, along with 250 mg dasabuvir (ABT-333) with or without ribavirin, administered twice daily. The European Medicines Agency (EMA) has granted accelerated assessment for the combination treatment. If approved, the regimen will be available for marketing in all 28 European Union member states.
AbbVie also submitted a new drug application to the FDA for the same investigational treatment. The FDA assigned the treatment breakthrough therapy designation in May 2013, granting it priority review.
According to the company, the applications submitted to the EMA are supported by data from six phase 3 studies with more than 2,300 patients conducted in more than 25 countries.
“These regulatory submissions bring us closer to offering adult genotype 1 chronic hepatitis C patients an all-oral, interferon-free regimen, which has the potential to provide a promising advancement for the hepatitis C community in the European Union,” Scott Brun, MD, vice president of pharmaceutical development for AbbVie, said in the release. “This regulatory milestone, on the heels of our submission of a new drug application in the US, represents an important step for our pipeline.”